Freudenberg Medical LLC
Medical Device
NewProductIntroductionEngineerII
“New Product Introduction Engineer II at Freudenberg Medical LLC. Skills: New product introduction, Process validation, Risk management. Execute development, prototyping, testing. Support NPI project planning”
What You'll Achieve.
Ensure timelines, budgets, and customer requirements are met; Support robust product and process development; Ensure scalable, compliant manufacturing solutions
Industry & Context.
Resolve technical issues; Root cause analysis
What They're Looking For.
Must Have
Bachelor's/University degree in Engineering (Mechanical, Biomedical etc. ) or related science/technical field, 3+ years’ experience in a medical device or related industry experience, Understanding of relevant ISO standards, Knowledge of GMP principles, Understanding of process validation principles, Intermediate knowledge of quality control tools, Familiarity with product testing and inspection methods
What You'll Do.
Support NPI project planning
Collaborate with internal teams
Plan and execute process validation
Provide hands-on support
Contribute to feasibility studies
Engage in cross-functional communication
Support management of QMS activities
How You'll Work.
Team & Collaboration
Collaborate with internal teams, customers, and suppliers; Engage in cross-functional communication and external collaboration; Align project goals; Manage stakeholders
Communication Scope
Cross-functional communication; External collaboration
Process & Methodology
Support planning and executing NPI projects, Ensuring timelines, budgets, and customer requirements are met, Facilitate NPI project timelines
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